Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213977
Company: TEVA PHARMS USA

Products on ANDA 213977

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONSURA	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213977

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213977

ONSURA

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.035MG/24HR;0.15MG/24HR
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETHINYL ESTRADIOL AND NORELGESTROMIN	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB	213950	AMNEAL
ETHINYL ESTRADIOL AND NORELGESTROMIN	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB	214594	ZYDUS NOVELTECH INC
ONSURA	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB	213977	TEVA PHARMS USA
XULANE	ETHINYL ESTRADIOL; NORELGESTROMIN	0.035MG/24HR;0.15MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB	200910	MYLAN TECHNOLOGIES